U.S. patent application number 10/331561 was filed with the patent office on 2004-04-15 for medical device sheath apparatus and method of making and using same.
Invention is credited to Friedman, Marc David, Moynihan, Shawn Timothy, Smith, Anthony Mark.
Application Number | 20040073088 10/331561 |
Document ID | / |
Family ID | 32072935 |
Filed Date | 2004-04-15 |
United States Patent
Application |
20040073088 |
Kind Code |
A1 |
Friedman, Marc David ; et
al. |
April 15, 2004 |
Medical device sheath apparatus and method of making and using
same
Abstract
A medical device sheath apparatus including: a fitting being
suitable for receiving the medical device in a self sealing manner;
a first sheath for receiving the medical device as it passes
through the fitting; a second sheath surrounding the first sheath;
a dilator defining a treatment area, coupled to at least the second
sheath, and being suitable for dilating a bodily cavity and passing
therapeutic or diagnostic energy in such forms as electromagnetic
radiation or acoustic energy there through; and, a window
operatively positioned with respect to the first sheath so as to
enable viewing of an area substantially adjacent the second sheath
upon insertion of the medical device into the apparatus. A method
for irradiating at least a portion of a bodily cavity including:
providing a sheath apparatus including: a fitting being suitable
for receiving the medical device in a self sealing manner; a first
sheath for receiving the medical device as it passes through the
fitting; a second sheath surrounding the first sheath; a dilator
defining a treatment area, coupled to at least the second sheath,
and being suitable for dilating a bodily cavity and passing
therapeutic or diagnostic energy in such forms as electromagnetic
radiation or acoustic energy there through; and, a window
operatively positioned with respect to the first sheath so as to
enable viewing of an area substantially adjacent the second sheath
upon insertion of the medical device into the apparatus; inserting
at least a portion of the medical device into the apparatus;
positioning the medical device containing apparatus in the bodily
cavity using direct viewing through the window and the medical
device; and, irradiating the portion of the bodily cavity through
the apparatus using the medical device. A method for making a
medical device sheath apparatus including: coupling a first sheath
to a fitting being suitable for receiving the medical device in a
self sealing manner; coupling a second sheath to the fitting so as
to surround the first sheath; coupling a dilator defining a
treatment area and being suitable for dilating a bodily cavity and
passing therapeutic or diagnostic energy in such forms as
electromagnetic radiation or acoustic energy there through to the
second sheath; and, coupling the first sheath to a window
operatively positioned with respect to the first sheath so as to
enable viewing of an area substantially adjacent the second sheath
upon insertion of the medical device into the apparatus.
Inventors: |
Friedman, Marc David;
(Needham, MA) ; Moynihan, Shawn Timothy; (Lowell,
MA) ; Smith, Anthony Mark; (Medway, MA) |
Correspondence
Address: |
REED SMITH LLP
2500 ONE LIBERTY PLACE
1650 MARKET STREET
PHILADELPHIA
PA
19103
US
|
Family ID: |
32072935 |
Appl. No.: |
10/331561 |
Filed: |
December 30, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60418664 |
Oct 15, 2002 |
|
|
|
Current U.S.
Class: |
600/114 |
Current CPC
Class: |
A61B 1/00142 20130101;
A61B 1/00135 20130101; A61B 2017/22051 20130101; A61B 1/2733
20130101; A61B 1/00082 20130101; A61N 5/0601 20130101; A61B
2018/00982 20130101 |
Class at
Publication: |
600/114 |
International
Class: |
A61B 001/00 |
Claims
What is claimed is:
1. A medical device sheath apparatus comprising: a fitting being
suitable for receiving said medical device in a self sealing
manner; a first sheath for receiving said medical device as it
passes through said fitting; a second sheath surrounding said first
sheath; a dilator defining a treatment area, coupled to at least
said second sheath, and being suitable for dilating a bodily cavity
and passing therapeutic electromagnetic radiation there through;
and, a window operatively positioned with respect to said first
sheath so as to enable viewing of an area substantially adjacent
said second sheath upon insertion of said medical device into said
apparatus.
2. The apparatus of claim 1, wherein said medical device comprises
an endoscope comprising a channel suitable for receiving an optical
fiber suitable for irradiating biologic material through said
dilator.
3. The apparatus of claim 1, wherein said dilator is substantially
non-distensible.
4. The apparatus of claim 1, wherein said fitting comprises: a seal
housing; and, a seal secured by said housing and comprising a bore
being suitable for receiving said medical device and sized to
provide an air seal against an outside diameter of said medical
device.
5. The apparatus of claim 4, further comprising at least one
additional bore being suitable for receiving at least one tube for
inflating or deflating said dilator.
6. The apparatus of claim 4, wherein said seal comprises at least
one elastomeric material.
7. The apparatus of claim 4, wherein said seal is mechanically or
pneumatically actuatable.
8. The apparatus of claim 4, further comprising at least one
retainer securing said seal to said housing.
9. The apparatus of claim 8, wherein said seal, housing and
retainer are integral.
10. The apparatus of claim 1, further comprising a tube having an
end positioned with respect to said window to enable introduction
of a material substantially adjacent to said window through said
fitting.
11. The apparatus of claim 1, further comprising a tube having an
end positioned with respect to said window to enable evacuation of
material from an area substantially adjacent to said window through
said fitting.
12. The apparatus of claim 1, wherein said window is substantially
transparent.
13. The apparatus of claim 12, wherein said window comprises at
least one anti-reflective coating.
14. The apparatus of claim 1, wherein said dilator further
comprises at least one of a partially reflective coating and an
absorptive coating.
15. The apparatus of claim 14, wherein said coating comprises at
least one of gold, aluminum, silver, titanium oxide and carbon
black.
16. The apparatus of claim 8, wherein at least two of said housing,
seal and retainer are keyed.
17. The apparatus of claim 16, wherein said keying comprises at
least one notch.
18. The apparatus of claim 8, wherein said seal comprises a
plurality of fins suitable for mating with at least said housing or
retainer.
19. The apparatus of claim 18, wherein at least one of said housing
and retainer comprise a plurality of grooves suitable for receiving
said fins.
20. The apparatus of claim 1, wherein said first and second sheaths
are adapted such that said medical device provides sufficient
rigidity to insert said apparatus into a bodily cavity.
21. The apparatus of claim 1, wherein said first sheath and fitting
are coupled so as to permit a substantially distal portion of said
medical device to be displaceable within said treatment area.
22. The apparatus of claim 1, further comprising means for
inflating at least said dilator.
23. The apparatus of claim 22, wherein said means for inflating
further comprises means for inflating said first sheath.
24. The apparatus of claim 1, further comprising at least one
marking on said first sheath, second sheath or dilator being
suitable for determining a position of a substantially distal
portion of said medical device using said medical device.
25. The apparatus of claim 24, wherein said at least one marking is
directly viewable.
26. The apparatus of claim 1, wherein said first sheath and fitting
are configured to define a substantially closed space upon
insertion of said medical device.
27. The apparatus of claim 26, wherein said dilator and first
sheath define a second substantially closed space.
28. The apparatus of claim 8, wherein said retainer comprises a
plurality of channels.
29. The apparatus of claim 28, wherein said housing comprises a
plurality of projections positioned to mate with said channels when
said retainer and housing are coupled to one another.
30. The apparatus of claim 4, wherein said seal comprises: a disc
portion; an o-ring peripherally positioned with respect to said
disk portion; and, a tubular portion extending from said disk
portion; wherein said disk portion and tubular portion define at
least one bore suitable for receiving said medical device there
through.
31. The apparatus of claim 30, wherein said tubular portion
comprises a plurality of radially outwardly extending
protrusions.
32. The apparatus of claim 31, further comprising at least one
aperture passing through said disk portion, wherein said disk
portion is adapted to be compressed between said housing and
retainer.
33. The apparatus of claim 32, wherein said housing defines an
internal bore corresponding to said bore of said seal, and said
housing bore comprises a plurality of internal steps.
34. The apparatus of claim 33, wherein said housing further
comprises a first bonding location for said first sheath and a
second bonding location for said second sheath.
35. The apparatus of claim 34, wherein said housing further
comprises at least two substantially concentric cone portions
defining said first and second bonding locations.
36. A method for irradiating at least a portion of a bodily cavity
comprising: providing a sheath apparatus comprising: a fitting
being suitable for receiving said medical device in a self sealing
manner; a first sheath for receiving said medical device as it
passes through said fitting; a second sheath surrounding said first
sheath; a dilator defining a treatment area, coupled to at least
said second sheath, and being suitable for dilating a bodily cavity
and passing therapeutic or diagnostic energy there though; and, a
window operatively positioned with respect to said first sheath so
as to enable viewing of an area substantially adjacent said second
sheath upon insertion of said medical device into said apparatus;
and, inserting at least a portion of said medical device into said
apparatus; positioning said medical device containing apparatus in
said bodily cavity using direct viewing through said window and
said medical device; and, irradiating said portion of said bodily
cavity through said apparatus using said medical device.
37. The method of claim 36, further comprising partially
withdrawing said medical device with respect to said apparatus
prior to said irradiating, and advancing an irradiating device
through said medical device to facilitate said irradiating, wherein
said apparatus positioning remains substantially unchanged during
said partial withdrawing of said device and advancing of said
irradiating device.
38. The method of claim 37, further comprising withdrawing said
irradiating device through said medical device after to said
irradiating, and advancing said medical device with respect to said
apparatus after said irradiating.
39. The method of claim 38, further comprising dilating said
portion of said bodily cavity prior to said irradiating using said
device containing apparatus.
40. The method of claim 39, further comprising un-dilating said
bodily cavity after said irradiating using said apparatus.
41. The method of claim 40, further comprising removing said device
containing apparatus after said irradiating.
42. The method of claim 36, wherein said positioning and
irradiating occur in a single insertion into said bodily
cavity.
43. The method of claim 36, wherein said medical device includes an
irradiating device, further comprising partially withdrawing said
medical device with regard to said apparatus, wherein said
apparatus and irradiating device positioning with respect to said
bodily cavity remains substantially unchanged during said partial
withdrawing of said medical device.
44. A method for making a medical device sheath apparatus
comprising: coupling a first sheath to a fitting being suitable for
receiving said medical device in a self sealing manner; coupling a
second sheath to said fitting so as to surround said first sheath;
coupling a dilator defining a treatment area and being suitable for
dilating a bodily cavity and passing therapeutic electromagnetic
radiation there through to said second sheath; and, coupling said
first sheath to a window operatively positioned with respect to
said first sheath so as to enable viewing of an area substantially
adjacent said second sheath upon insertion of said medical device
into said apparatus.
45. The method of claim 44, further comprising passing at least one
air, water or suction line through said fitting.
46. The method of claim 45, further comprising banding said at
least one air, water or suction line to said inner sheath.
47. The method of claim 45, further comprising securing said at
least one of said at least one air, water or suction line
substantially adjacent to said window.
48. The method of claim 44, further comprising coupling said second
sheath to said window.
49. A medical device sheath apparatus comprising: a fitting being
suitable for receiving said medical device; a seal being suitable
for receiving said medical device through said fitting; a sheath
for receiving said medical device through said fitting and seal; a
dilator defining a treatment area, coupled to said sheath, and
being suitable for dilating a bodily cavity and passing energy
therethrough; and, a window operatively positioned with respect to
said sheath so as to enable viewing of an area substantially
adjacent to said sheath upon insertion of said medical device into
said apparatus.
50. The apparatus of claim 49, wherein said medical device
comprises an endoscope comprising a channel or attachment suitable
for receiving an instrument suitable for passing a form of energy
through said dilator.
51. The apparatus of claim 50, wherein said endoscope comprises at
least one of an irradiating fiber and ultrasound transducer.
52. The apparatus of claim 49, wherein at least one of said dilator
and sheath is substantially non-distensible.
53. The apparatus of claim 49, wherein at least one of said dilator
and sheath is substantially distensible.
54. The apparatus of claim 49, wherein said fitting comprises: a
seal housing; and, a seal secured in said housing and comprising a
bore being suitable for receiving said medical device and sized to
provide an air seal against an outside diameter of said medical
device.
55. The apparatus of claim 54, further comprising at least one
retainer securing said seal to said housing.
56. The apparatus of claim 55, wherein said seal, housing and
retainer are integral.
57. The apparatus of claim 54, further comprising at least one
additional bore being suitable for receiving at least one tube for
inflating or deflating said dilator.
58. The apparatus of claim 54, wherein said seal comprises at least
one elastomeric material.
59. The apparatus of claim 54, wherein said seal is mechanically or
pneumatically actuatable.
60. The apparatus of claim 49, further comprising a tube having an
end positioned with respect to said window to enable introduction
of a material substantially adjacent to said window through said
fitting.
61. The apparatus of claim 49, further comprising a tube having an
end positioned with respect to said window to enable evacuation of
material from an area substantially adjacent to said window through
said fitting.
62. The apparatus of claim 49, wherein said window is substantially
transparent.
63. The apparatus of claim 62, wherein said window comprises at
least one anti-reflective coating.
64. The apparatus of claim 49, wherein said dilator further
comprises at least one of a reflective, partially reflective and
absorptive coating.
65. The apparatus of claim 64, wherein said coating comprises at
least one of gold, aluminum, silver, titanium oxide and carbon
black.
66. The apparatus of claim 55, wherein at least two of said
housing, seal and retainer are keyed.
67. The apparatus of claim 49, wherein said sheath is sufficiently
flexible such that said medical device provides sufficient rigidity
to insert said apparatus into a bodily cavity.
68. The apparatus of claim 49, wherein said sheath and fitting are
coupled so as to permit a substantially distal portion of said
medical device to be displaceable within said treatment area.
69. The apparatus of claim 49, further comprising means for
inflating at least said dilator.
70. The apparatus of claim 69, wherein said means for inflating
further comprises means for inflating said sheath.
71. The apparatus of claim 49, further comprising at least one
marking on said sheath, medical device or dilator being suitable
for determining a position of a substantially distal portion of
said medical device.
72. The apparatus of claim 71, wherein said at least one marking is
directly viewable using said medical device.
73. The apparatus of claim 49, wherein said sheath and fitting are
configured to define a substantially closed space upon insertion of
said medical device.
74. The apparatus of claim 71, further comprising a second sheath
secured to said fitting such that said dilator and second sheath
define a second substantially closed space.
75. The apparatus of claim 54, wherein said seal comprises: a disc
portion; an o-ring peripherally positioned with respect to said
disk portion; and, a tubular portion extending from said disk
portion; wherein said disk portion and tubular portion define at
least one bore suitable for receiving said medical device there
through .
76. The apparatus of claim 75, further comprising at least one
aperture passing through said disk portion, wherein said disk
portion is adapted to be compressed between said housing and
retainer.
77. The apparatus of claim 54, wherein said housing defines an
internal bore corresponding to said bore of said seal, and said
housing bore comprises a plurality of internal steps.
78. The apparatus of claim 77, wherein said housing further
comprises a first bonding location for said first sheath and a
second bonding location for said second sheath.
79. The apparatus of claim 78, wherein said housing further
comprises at least two substantially concentric cone portions
defining said first and second bonding locations.
80. A method for making a medical device sheath apparatus
comprising: coupling a first sheath to a fitting being suitable for
receiving said medical device in a self sealing manner; coupling a
second sheath to said fitting so as to surround said first sheath;
coupling a dilator defining a treatment area and being suitable for
dilating a bodily cavity and passing therapeutic or diagnostic
energy there through to said second sheath; and, coupling said
first sheath to a window operatively positioned with respect to
said first sheath so as to enable viewing of an area substantially
adjacent said second sheath upon insertion of said medical device
into said apparatus.
Description
RELATED APPLICATION
[0001] This application claims priority of U.S. patent application
Ser. No. 60/418,664, entitled MEDICAL DEVICE SHEATH APPARATUS AND
METHOD OF MAKING AND USING SAME, filed Oct. 15, 2002, the entire
disclosure of which is hereby incorporated by reference as if being
set forth in its entirety herein.
FIELD OF THE INVENTION
[0002] The present invention relates generally to systems and
methods for treating medical conditions, and more particularly to
systems and methods for treating medical conditions associated with
a body cavity or lumen.
BACKGROUND OF THE INVENTION
[0003] Endoscopes are generally used to examine various biological
cavities, such as those in the alimentary canal or the bladder.
Such may be biological cavities of a human or otherwise. A
physician typically has a limited view of the interior of the
cavity in which the distal end of the endoscope is located, due to
the fact that tube like organs, such as the esophagus, intestine,
and bladder, may be relatively soft and pliable such that the organ
collapses about the endoscope. In order to have a better view of
the cavity, air or liquid (such as water) may be traditionally
forced into the cavity causing the cavity to temporarily
expand.
[0004] Devices have generally been developed to distend tube-like
organs with hardened or scarred tissue. One such device used by
physicians is the balloon catheter. In the cardiovascular system,
balloon catheters are used to open blocked or significantly
narrowed arteries. In the gastrointestinal system, a modified
balloon catheter, or balloon dilator, may be used to exert a radial
force on the surrounding walls of tube-like organs, for the purpose
of dilating strictures. Balloon dilators are commonly used in the
gastrointestinal tract for strictures of the esophagus, pylorus,
duodenum, sphincter of odi, biliary tree and colon.
[0005] Balloon catheters and dilators have also been used for
expansion without the exertion of large radial forces. These
balloon dilators are instead used to hold an organ open for an
extended period of time, usually for a treatment of some kind. This
treatment may include delivering medicaments to a specific site
within the cardiovascular system, or the activation of a
photosensitizing agent in a variety of organs, for example.
[0006] Devices have also been proposed to expand non-tubular organs
in order to create a uniform surface for the activation of a
photosensitizing agent. Such organs include the uterus and the
bladder, for example.
[0007] Regardless, such distending devices may conventionally be
positioned with respect to a target tissue with the aid of
guidewires, or specialized introducers, being passed through the
lumen of an endoscope, or by being passed "blindly" through
connecting body lumens. However, there is typically no direct
viewing of the positioning procedure or the target tissue.
Therefore, difficulties exist in remotely and effectively treating
a disease or ailment. Further, using guidewires typically requires,
multiple insertions into the cavity to perform a treatment.
Generally, the more insertions required, the greater the chance for
damage to surrounding tissue. For example, in a typical guidewire
related gastrointestinal PDT procedure, a physician typically first
inserts an endoscope to determine the treatment site. Once the site
is located, a guidewire is typically inserted into the instrument
channel of the endoscope. The endoscope is then withdrawn and the
guidewire is left behind at the treatment site. Next, a balloon
dilator is typically inserted using the guidewire as a central
axis. To view the site, the endoscope is then reinserted alongside
the dilator. When the procedure is complete, all devices are
removed from the site.
[0008] In situations where devices are passed either through an
endoscope or are passed "blindly", there is a risk that the device
may not be properly positioned at the target tissue, or more
significantly, pass into unintended tissue and/or lumens causing
harm to the patient. It is generally desirable to mitigate this
risk. Further, it is generally desirable to minimize the number of
insertions that must be performed to treat an area of interest.
SUMMARY OF THE INVENTION
[0009] A medical device sheath apparatus including: a fitting being
suitable for receiving the medical device in a self sealing manner;
a first sheath for receiving the medical device as it passes
through the fitting; a second sheath surrounding the first sheath;
a dilator defining a treatment area, coupled to at least the second
sheath, and being suitable for dilating a bodily cavity and passing
therapeutic or diagnostic energy in such forms as electromagnetic
radiation or acoustic energy there through; and, a window
operatively positioned with respect to the first sheath so as to
enable viewing of an area substantially adjacent the second sheath
upon insertion of the medical device into the apparatus.
[0010] A method for irradiating at least a portion of a bodily
cavity including: providing a sheath apparatus including: a fitting
being suitable for receiving the medical device in a self sealing
manner; a first sheath for receiving the medical device as it
passes through the fitting; a second sheath surrounding the first
sheath; a dilator defining a treatment area, coupled to at least
the second sheath, and being suitable for dilating a bodily cavity
and passing therapeutic or diagnostic energy in such forms as
electromagnetic radiation or acoustic energy there through; and, a
window operatively positioned with respect to the first sheath so
as to enable viewing of an area substantially adjacent to the
second sheath upon insertion of the medical device into the
apparatus; inserting at least a portion of the medical device into
the apparatus; positioning the medical device containing apparatus
in the bodily cavity using direct viewing through the window and
the medical device; and, irradiating the portion of the bodily
cavity through the apparatus using the medical device.
[0011] A method for making a medical device sheath apparatus
including: coupling a first sheath to a fitting being suitable for
receiving the medical device in a self sealing manner; coupling a
second sheath to the fitting so as to surround the first sheath;
coupling a dilator defining a treatment area and being suitable for
dilating a bodily cavity and passing therapeutic or diagnostic
energy in such forms as electromagnetic radiation or acoustic
energy there through to the second sheath; and, coupling the first
sheath to a window operatively positioned with respect to the first
sheath so as to enable viewing of an area substantially adjacent
the second sheath upon insertion of the medical device into the
apparatus.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] Understanding of the present invention will be facilitated
by consideration of the following detailed description of the
preferred embodiments of the present invention taken in conjunction
with the accompanying drawings, in which like numerals refer to
like parts, and,:
[0013] FIG. 1 illustrates an isometric view of an apparatus
according to an aspect of the present invention;
[0014] FIG. 2 illustrates an isometric view of the apparatus of
FIG. 1 having a medical device partially inserted therein;
[0015] FIG. 3 illustrates a fitting suitable for use with the
apparatus of FIG. 1;
[0016] FIGS. 4A-4E illustrate various views of a seal retainer
suitable for use with the fitting of FIG. 3;
[0017] FIGS. 5A-5E illustrate various views of a seal suitable for
use with the fitting of FIG. 3;
[0018] FIGS. 6A-6F illustrate various views of a seal housing being
suitable for use with the fitting of FIG. 3;
[0019] FIGS. 7A-7D illustrate various views of a sheath lumens
suitable for use with the apparatus of FIG. 1;
[0020] FIGS. 8A-8F illustrate various views of an outer sheath
suitable for use with the sheath lumens of FIGS. 7A-7D;
[0021] FIGS. 9A-9F illustrate various views of a distal window
suitable for use with the apparatus of FIG. 1;
[0022] FIG. 10 illustrates an exploded view of the apparatus of
FIG. 1; and,
[0023] FIGS. 11A-11C illustrate cross-sectional views of the
apparatus of FIG. 2, having an endoscope positioned at various
positions therein for treatment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] It is to be understood that the figures and descriptions of
the present invention have been simplified to illustrate elements
that are relevant for a clear understanding of the present
invention, while eliminating, for purposes of clarity, many other
elements found in endoscopic systems and radiating treatment
methods. Those of ordinary skill in the art will recognize that
other elements are desirable and/or required in order to implement
the present invention. However, because such elements are well
known in the art, and because they do not facilitate a better
understanding of the present invention, a discussion of such
elements is not provided herein. The disclosure herein is directed
to all such variations and modifications to such systems and
methods known to those skilled in the art.
[0025] According to an aspect of the present invention, a sheath
like apparatus may be provided and used that may be advantageously
compatible with existing endoscopic equipment, and be used to
expand, directly view and irradiate target tissue within a body
cavity or lumen. It should be understood that while endoscope
sheaths have generally been developed in order to prevent pathogen
transfer from a cavity in which the scope is placed to the
instrument itself, and in turn from person to person, these devices
typically provide no other significant therapeutic benefits or
advantages.
[0026] According to an aspect of the present invention, there is
provided a sheath-like device which may be used in conjunction
with, or otherwise associated with such as by substantially
encasing, an endoscope and introduced into a body cavity or lumen.
Such a device may allow the cavity or lumen, or portion thereof
corresponding to a treatment area, to be formed or dilated to a
desired shape, so as to be substantially spherical, cylindrical,
ellipsoidal or ovoid, for example. According to an aspect of the
present invention, such a device may provide means to inspect,
diagnose and/or treat the cavity or lumen with electromagnetic
radiation, such as light or acoustic energy such as ultrasound.
Energy delivered in this manner may allow for more accurate
diagnosis or treatment than may otherwise be conventionally
possible. Provided energy may also effect treatment through direct
physical effect on surrounding tissue, such as by cauterization or
hypothermia, for example. Or, it may effect treatment by causing a
chemical reaction, such as in conjunction with a photosensitizing
agent or precursor present in target tissue, for example. According
to an aspect of the present invention, enhanced visualization of
the cavity or lumen being irradiated may be achieved.
[0027] According to an aspect of the present invention, there may
be provided and used a sheath-like apparatus into which an
endoscope may be inserted, so as to facilitate examination and
therapy within a biological cavity using a single insertion of the
apparatus. Near an end of the apparatus, a bladder or balloon
portion positionable with the aid of an elongated sheath portion
may be provided. The balloon portion may be inflated with a
suitable fluid, such as a liquid or gas, to thereby cause it to
swell and provide an outward force that may tend to dilate or
deform a biological cavity into which it is inserted. Such dilation
may be of a desirably and predictably smooth shape based upon
characteristics of the balloon so as to enhance uniformity or
irradiation or illumination provided therethrough. For example, the
balloon may be substantially nondistensible. Alternatively, it may
be desirable that the balloon portion be distensible or partially
distensible based upon intended operational characteristics.
[0028] According to an aspect of the present invention, the
apparatus may generally include a fitting which includes a seal
housing, a seal which is dimensioned to receive an endoscope while
creating a substantially air-tight seal about it, and a seal
retainer. The apparatus may generally include a substantially
transparent outer sheath including a non-distensible balloon; a
substantially transparent inner sheath; a substantially transparent
viewing window; a tube positioned between the inner and outer
sheaths being suitable for delivering at least one fluid, such as
air, to a distal end of the treatment apparatus, such as to
terminate distal to the balloon and/or viewing window for the
evacuation of matter that may accumulate distal to the balloon
and/or window during therapy; and a second tube which terminates
within the seal housing and is intended to transport a fluid or air
for the purpose of inflating the balloon. The viewing window may
have an antireflection coating on one or more surfaces.
[0029] The balloon may or may not have either a reflective,
partially reflective or absorptive coating applied to one or more
surfaces, or a portion thereof, to enhance and/or limit treatment
to a specific target area of tissue within a cavity. The balloon
may have an optical sensor or sensing fiber affixed to or embedded
in it.
[0030] By inserting an endoscope into the apparatus, sufficient
rigidity may be attained to allow the apparatus to be inserted into
a biological cavity such as an esophagus. Once inside the
esophagus, a physician may examine the inside of the esophagus by
looking through the transparent viewing window, rinse the interior
of the esophagus with water or saline that is introduced through
the apparatus, introduce air, suction liquid, and properly position
the apparatus for therapy. When properly positioned, air may be
introduced into the balloon causing the balloon to inflate. The
inflated balloon may substantially anchor the apparatus in the
biological cavity allowing the endoscope to be withdrawn a distance
equivalent to a treatment length. The treatment length may be
determined through the endoscope by visual reference to markings
within the apparatus or by visual reference to graduations on the
endoscope itself, for example. An energy delivering device, such as
a light emitting fiber, may then be inserted through an instrument
channel in the endoscope, until it contacts the viewing window or a
distal end of the apparatus, thereby exposing a portion of the
energy delivering device to the cavity, such as a length of light
emitting fiber suitable for treating a treatment area of tissue,
i.e., a treatment length.
[0031] Referring now to FIG. 1, there is shown an isometric view of
an apparatus 10 according to an aspect of the present invention.
Apparatus 10 generally includes three functional areas: a proximal
fitting 20, sheath lumens 30 and distal window 40. An
air/water/suction line 12 and inflation/deflation line 14 are shown
extending from the proximal fitting 20 of the apparatus 10.
[0032] Referring now also to FIG. 2, there is shown an isometric
view of the apparatus 10 of FIG. 1 having a medical device 50
partially inserted therein. Device 50 may generally take the form
of an apparatus or instrument for visually examining the interior
of a bodily canal or a hollow organ, such as the colon, bladder or
stomach. Device 50 may take the form of an endoscope or
gastroscope, for example. Device 50 may be referred to herein as an
endoscope for purposes of non-limiting explanation only. Endoscope
50 passes through proximal fitting 20 and into an enclosed space
formed by the sheath lumens 30. A radiation emitting device 60,
such as a light emitting fiber, is shown extending through a biopsy
or instrument channel of endoscope 50. Of course, any device being
suitable for emitting radiation at wavelengths selected for
therapeutic benefit of tissue and being inserted into device 50 may
be used. Additionally, emitting device 60 may be connected to an
activating source so as to couple emitted radiation into a
treatment cavity and cause irradiation of surrounding tissue. For
example, where device 60 takes the form of an optical fiber, a
laser or other suitable light-generating device (not shown)
optically coupled to the fiber may be used. Alternatively, device
60 may generate emitted radiation itself.
[0033] Terminal fittings of the air/water/suction line 12 and the
inflation/deflation line 14 may be respectively connected to
sources of air, water, or suction and pressure/vacuum respectively
(not shown). Endoscope 50 may be used in conjunction with apparatus
10, such that proximal fitting 20 may provide a primary interface
between apparatus 10 and endoscope 50. Proximal fitting 20 may
further provide a grip by which to maneuver apparatus 10.
[0034] Referring now also to FIG. 3, proximal fitting 20 generally
includes a seal retainer 70, seal 80 and seal housing 90. Sealing
may be largely accomplished using a suitable elastomeric material
or, alternatively, a mechanically or pneumatically actuated seal.
Seal retainer 70 and seal housing 90 may be acrylic in nature, but
may be formed of any suitable, non-porous material that would allow
for a good bonding surface for the other components as will be
understood by one possessing an ordinary skill in the pertinent
arts. Seal 80 may be formed of a parylene coated silicone, but may
be largely formed out of any suitable elastomeric material that may
have applied to it, a friction reducing coating. Seal retainer 70,
seal 80 and housing 90 may be designed to take advantage of a
repeatable manufacturing process, such as injection molding.
[0035] Referring now also to FIGS. 4A-4D, there are shown various
views of a seal retainer suitable for use as seal retainer 70 of
FIG. 3. Seal retainer 70 may generally take the form of a truncated
cone having a small taper suitable for creating a locking fit with
a mating portion of seal housing 90, as well to aid in ejection
during a molding process, for example. A countersink like through
hole or aperture 72 may be provided to guide a distal tip of
endoscope 50 into place so as to pass through retainer 70 and into
sheath portion 30 (FIGS. 1 and 2). Retainer 70 may also include two
through holes or apertures 74 sized to fit a strain relief for
inflation/deflation 12 and air/water suction 14 lines (FIGS. 1 and
2). Along an outer tapered surface of retainer 70 may be provided a
key like feature 76 suitable for dictating positioning during
assembly. This may serve to mitigate a risk of misalignment with
mating holes in seal 80. Referring now also to FIGS. 5A-5D, there
are shown various views of a seal suitable for use as seal 80 of
FIG. 3. Seal 80 may be configured to provide multiple seals. Seal
80 may generally comprise a flat disk portion 82 and an o-ring-like
gasket 84 that lies around a perimeter of the disk 82 and a tubular
portion 86 extending longitudinally from disk 82. Seal 80 may
further include a bore 81 through disk 82 and tubular portion 86.
Tubular portion 86 may be relatively thin walled to accommodate
bore 81. Disk 82 and o-ring 84 may be compressed between a distal
face of seal retainer 70 and a step in a bore of seal housing 90
when assembled therewith.
[0036] Seal 80 may further include a plurality, such as four (4),
fin like protrusions 83 extending outwardly from and along tubular
portion 86 of seal 80. Of course, any suitable shape for portion 83
may be used though. These protrusions may serve to provide rigidity
to tubular portion 86 to prevent roll back upon removal of
endoscope 50. Second, when fully assembled in seal housing 90, the
distal face of the fins may contact at least one protrusion within
the housing 90 to prevent elongation and therefore narrowing of
seal 80 when endoscope 50 is inserted through bore 81.
[0037] Seal 80 may further include apertures 89 passing through
disk portion 82 and being suitable for passing air/water/suction
line 12 and inflation/deflation line 14 therethrough. Apertures 89
may be undersized in comparison to tubes being passed through them.
Further, disk 82 may include a relatively thicker portion 87
through which apertures 83 pass to provide a greater sealing
surface along the length of the inserted lines 12, 14 as they pass
through seal 80. Portion 87 of increased thickness may also be
configured to act as a key, forcing alignment of apertures 89 of
the seal 80 with apertures 74 through seal retainer 70 (FIG. 4A) as
well as with apertures through seal housing 90 which correspond to
lines 12, 14.
[0038] Seal 80 may provide a seal between seal retainer 70 and seal
housing 90. Seal 80 may provide a seal about lines 12, 14 where
they pass through apertures 89. Seal 80 may provide for a seal
between an inner wall of tubular portion 86 and endoscope 50 when
endoscope 50 is passed through bore 81. An inner diameter of
tubular portion 86 may be relatively undersized, such that when
endoscope 50 is passed therethrough, tubular portion 86 expands to
allow endoscope passage.
[0039] Wall thickness and durometer of silicone composing seal 80
may be adjusted during manufacturing to obtain desired radial force
operability. By adjusting the seal length and applying a parylene
coating during manufacturing, the friction between the seal and the
scope can be adjusted to allow for smooth insertion and removal of
the endoscope into and from apparatus 10, for example. The desired
friction may also be set so that movement of endoscope 50 relative
to the sheath assembly 10 should not inadvertently occur during
use, absent force being applied to endoscope 50 by a physician, for
example. Tubular portion 86 may be tapered at one or both
longitudinal ends to ease insertion and/or removal of endoscope 50,
for example. As will be recognized by one possessing an ordinary
skill in the pertinent arts, when all three seals are effected,
apparatus 10 defines a substantially closed system that can be
pressurized.
[0040] Referring now also to FIGS. 6A-6F, there are shown various
views of a seal housing being suitable for use as seal housing 90
of FIG. 3. Seal housing 90 may serve primarily as a transition
piece from seal 80 to sheath lumens 30 (FIG. 1). Housing 90 may
generally take the form of a series of concentric cones forming a
plurality of steps in an internal bore thereof, for example.
[0041] Housing 90 may include a portion 92 adapted to receive and
position seal retainer 70. A first step that decreases the inner
diameter of housing 90 may mate with flat disk portion 82 of seal
80, so as to cooperate as a sealing face. This first step may
further include a small channel along its perimeter that mates with
o-ring portion 84 of seal 80. A second portion 94 may include
internally projecting fins 95 similar to fins 83 (FIG. 5A) to
facilitate securing seal retainer 70 in a substantially centralized
position within a bore of housing 90 and reduce seal elongation by
retaining a proximal end of seal 80. Fins 95 may be spaced to
facilitate alignment of seal 80. Substantially adjacent a
longitudinal end of portion 94 substantially distal to portion 92,
a small thin walled protrusion 93 that acts as a positive stop for
fins 83 of seal 80, preventing elongation upon endoscope insertion,
may be provided. Further, two apertures 97, 99 passing through this
same end of portion 94 substantially distal from portion 92 may be
provided. A larger of the two apertures 99 may be substantially
centralized and sized to allow endoscope 50 passage. Aperture 99
may also pass through a tapered protrusion 98 that for a more
proximal portion, substantially adjacent to section 94, may be
teardrop shaped in cross section. An exterior surface of the tear
dropped portion of protrusion 98 may serve as a bonding site for an
outer sheath, as will be discussed. Protrusion 98 may then step
down to a substantially circular cross-section, which may serve as
a bonding site for an inner sheath, as will be discussed. Aperture
97 may be smaller, and adapted to pass through only the teardrop
shaped portion of protrusion 98, exiting at or near the step down
to the smaller, substantially circular cross-section. Aperture 97
may be used to provide access to a space between inner and outer
sheaths, allowing for passage of the air/water/suction line 12 and
inflation/deflation line 14. Aperture 97 may be positioned with
reference to other keying features in the proximal fitting
components to allow for a straight run, or substantially straight
run, of the air/water/suction line 12 and/or inflation/deflation
line 14.
[0042] Referring now also to FIGS. 7A-7D, there are shown various
views of a sheath lumens suitable for use as sheath lumens 30 of
FIG. 1. Sheath lumens 30 generally includes an inner sheath 32,
air/water/suction line 12, inflation/deflation line 14, and an
outer sheath/balloon 34. Inner sheath 32 and outer sheath/balloon
34 may be formed of Polyethylene Terephthalate (PET).
Air/water/suction line 12 and inflation/deflation line 14 may be
formed of Pebax 72D. Of course, either sheath 32, 34 or lines 12,
14 could be made out of any suitably flexible, thin walled plastic
tubing or elastomeric material. According to an aspect of the
present invention, an optically clear or radiation transmissive
material may be utilized so as to pass treatment radiation
therethrough and/or allow for direct visualization of an inflated
biologic cavity. For example, non-compliant materials such as
thermoplastics may make suitable choices.
[0043] Generally, inner sheath 32 may take the form of a thin
walled (for example 0.001") tube that runs substantially the length
of the sheath 30. A first end of inner sheath 32 may be tapered to
fit over the tapered, circular cross section distal protrusion 98
of seal housing 90. An inner diameter of inner sheath 32 may be
sized to allow passage of endoscope 50 therethrough. Inner sheath
32 may also serve to effectively limit an area in which optical
fiber 60 (FIG. 2) used in treatment will be able to wander.
[0044] Generally, air/water/suction line 12 may be small in
diameter (for example having a 0.072" outer diameter) and run
substantially the length of sheath 30. Line 12 may terminate
substantially at or near distal window 40. As set forth, line 12
may further pass through proximal fitting 20. Further, from the
proximal fitting 20 a length of tubing may continue as a pigtail,
terminating at a luer lock fitting, for example. To prevent
movement of line 12, it may be banded to inner sheath 32.
Accordingly, endoscope 50 may be effectively insulated from
air/water/suction line 12 by inner sheath 32.
[0045] Generally, inflation/deflation line 14 may be small in
diameter (for example having a 0.072" outer diameter) and terminate
in a substantially free floating manner within seal housing 90
(FIG. 6A). As set forth, line 14 may further pass through proximal
fitting 20. Further, from the proximal fitting 20 a length of
tubing may continue as a pigtail, terminating at a luer lock
fitting, for example. To prevent movement of line 14, it may also
be banded to inner sheath 32. Accordingly, endoscope 50 may be
effectively isolated from inflation/deflation line 14 by inner
sheath 32.
[0046] Referring now also to 8A-8F in conjunction with 7A-7D in
particular, there are shown various views of an outer sheath
suitable for use as outer sheath/balloon 34 of FIGS. 7A-7D.
According to an aspect of the present invention, outer
sheath/balloon 34 may be seen to generally include a proximal taper
100, a cylindrical main lumen 102, a balloon 104 and a distal
mating portion 106. The last two features can be a separate
component from the other two, or integrally formed therewith. The
outer sheath/balloon 34 may take the form of a thin walled (0.001")
tube. A cross section of taper 100 may be generally tear drop in
shape, designed to mate with the protrusion 98 of the same shape of
seal housing 90. An elongated cylindrical main lumen 102 may be set
off-axis from inner sheath 32 so as to allow for the passage of the
air/water/suction line 12. A small cavity may be formed between
inner sheath 32 and outer sheath 34 along the length. The shape of
balloon portion 104 may at least partially depend on the type of
biological cavity it is intended to be inflated in. In the
illustrated, non-limiting instance it is shown as cylindrical, with
an abrupt proximal and distal ending that may be suitable to fit
within a patient's esophagus. The length and diameter of the
balloon 104 cylinder can be manufactured in a variety of sizes
depending on treatment requirements. Balloon 104 may also be coated
on specific sections or in a pattern like manner to provide a
specific treatment area, improve light efficiency to the treatment
area, or improve uniformity, for example. Suitable coatings may be
reflective, such as titanium oxide, gold, aluminum, silver or other
metals in the case of light irradiation. Suitable coatings may be
absorptive, such as carbon black in the case of light irradiation.
Such coating may at least partially define treatment area within a
biological cavity which balloon 104 is inserted, by facilitating
unidirectional irradiation for example. Balloon 104 may be
semi-permeable, to allow an oxygenated fluid passage to tissue
being treated. Distal mating portion 106 may be of a generally
teardrop cross section that is designed to mate with distal window
40 (FIG. 1). This section 106 may be positioned so as to realign
the axis of the outer sheath 34 to the inner sheath 32 and distal
window 40 (FIG. 1). The balloon portion may be bonded to outer
sheath main lumen 102.
[0047] Referring now also to FIGS. 9A-9F, there are shown various
views of a distal window suitable for use as distal window 40 of
FIG. 1. Generally, distal window 40 may take the form of a
substantially planar, non-planar or lens shaped member, by way of
non-limiting example only, that may be made of acrylic to provide a
substantially optically clear, non-distorting window. Of course,
any other material that provides these features and may be bonded
to may be acceptable for use. Window 40 generally includes a
tapered protrusion 42 with a circular cross section to provide a
bonding site for inner sheath 32 (FIGS. 7A-7D). Window 40 may then
step up to a tapered section 94 with a teardrop cross section
suitable for providing a bonding site for outer sheath/balloon 34.
A small ridge 46 may serve as a positive stop for outer
sheath/balloon 34. Passing through the bonding site for the outer
sheath/balloon 34 may be a small oval or ellipse shaped bore 48,
which has a small step within it, and is hooded 49 on an end
opposite to protrusion 42. Bore 48 may be designed to accept a
distal end of the air/water/suction line 12 such that the internal
step is positioned to act as a positive stop preventing over
insertion. Hood 49 may serve to direct a stream of fluid passing
through air/water/suction line 12 down across distal window 40. The
deflecting surface of the hood may be angled so that the fluid
passes over an outer surface of window 40. Viewing windows may be
placed at other positions relative to balloon 104 as will be well
understood by those possessing an ordinary skill in the pertinent
art though. Further, viewing may be facilitated directly through
balloon 104, for example, such that balloon 104 itself forms a
viewing window.
[0048] Referring now also to FIG. 10, there is shown an exploded
view of an embodiment of apparatus 10 of FIG. 1. Apparatus 10 of
FIG. 10 may be assembled in the following manner. Inner sheath 32
may be adhered to seal housing 90. The air/water/suction line 12
may be fed through aperture 97 in seal housing 90 such that a
length slightly longer than the distal end of inner sheath 32 is
provided. The air/water/suction line 12 may then be banded to the
inner sheath 32. An area of the inner sheath 32 corresponding to
balloon 104 is preferably not banded. Outer sheath 34 may then be
adhered to housing 90. Balloon 104 may then be slid onto the outer
sheath 34 such that a distal end of balloon 104 is behind, or
shorter than, a distal end of inner sheath 32. Air/water/suction
line 12 may then be fed into and secured within aperture 48 of
window 40, such as by adhering. Inner sheath 32 may then be adhered
to the corresponding area of portion 42 of distal window 40, taking
care to ensure that the air/water/suction line 12 remains
substantially in-line. Balloon 104 may then be adhered up to the
ridge 46 on window 40 and to the outer sheath 34. Seal 80 may then
be inserted into seal housing 90 while feeding air/water/suction
line 12 through one of the apertures 89, such as a left one, taking
care to ensure full seating of seal 80. Inflation/deflation line 14
may then be fed through the other of the apertures 89 in the seal
80. The air/water/suction and inflation/deflation lines 12, 14 may
then be fed through apertures 74 of seal retainer 70. Seal retainer
70 may then be fully seated within housing 90 such that the
proximal faces thereof are substantially in plane. The
air/water/suction and inflation/deflation lines 12, 14 may then be
cut to provide pigtails of appropriate length, such as 25 cm.
Strain reliefs 110 may then be slid onto and adhered to the ends of
the air/water/suction and inflation/deflation lines 12, 14.
Suitable strain reliefs may take the form of thin Pellethane tubes,
for example. Female luer locks may then be secured to the free ends
of the air/water/suction and inflation/deflation lines 12, 14, and
attached to the strain reliefs.
[0049] In use, endoscope 50 may be inserted through the seal
retainer 70, seal 80 and seal housing 90, and into the inner sheath
32 such that the distal end of the endoscope 50 becomes proximate
to the distal end of the inner sheath 32 (i.e., adjacent to the
viewing window 40). When endoscope 50 is fully inserted, sheaths
32, 34 may become less flexible in nature due to the more radially
rigid endoscope 50 housed within them and is ready to be used in a
biological cavity (e.g., an esophagus).
[0050] When the distal portion of endoscope 50 is proximate to the
distal end of the inner sheath 32, endoscope 50 may be positioned
to receive, and transmit, images of a cavity in which the sheath
and endoscope are inserted; through the viewing window 40. If the
viewing window becomes hazy or is covered by matter (which may be,
for example, biological in nature), a physician can direct water or
air through the air/water/suction line 12 to remove the matter from
the viewing window 40. Similarly, if sufficiently small matter
and/or fluid in nature should become adjacent to window 40, the
matter may be removed by sucking it through the air/water/suction
line 12.
[0051] By injecting a suitable material, such as a gas, air or
liquid for example, between the inner and outer sheaths 32, 34 (by
using inflation/deflation line 14 for example), balloon 104 will
tend to inflate and deform a biologic cavity in which it is
inserted. Similarly, if fluid pumped into apparatus 10 is withdrawn
(for example, by sucking the fluid back out through
inflation/deflation line 12), the space between inner and outer
sheaths and between the inner sheath and endoscope scope will
deflate.
[0052] Referring now to FIGS. 11A and 11 B, there are illustrated
cross-sectional views showing the distal end of the endoscope 50 at
a first position proximate the distal end of the inner sheath 32
wherein the balloon 104 is in a deflated state and adjacent a
target region of a biologic cavity. When in this first position,
the balloon 104 may be inflated (by pumping air, water, etc.
through the inflation line 12 to expand the target region by making
a uniform shape, for example). Simultaneously, the space between
the inner and outer sheaths 32, 34, and/or between the inner sheath
and the endoscope may be inflated.
[0053] The target region may be affected by a disease or ailment
such as Barrett's Esophagus and may additionally contain a
photosensitizing agent or precursor such as that described in U.S.
Pat. Nos. 5,955,490, 5,422,093, 5,234,940, 5,211,938, 5,097,262 and
in James C. Kennedy et al., Photodynamic Therapy (PDT) and
Photodiagnosis (PD) Using Endogenous Photosensitization Induced by
5-Aminolevulinic Acid (ALA): Mechanisms and Clinical Results, 14 J.
CLINICAL LASER MEDICINE & SURGERY 289-304 (1996), each of which
is incorporated herein by reference in its entirety.
[0054] After the balloon 104 is inflated, the physician may pull on
the endoscope 50 while holding the proximal fitting 20 thereby
withdrawing the endoscope 50 relative to the viewing window 40; the
endoscope being proximally withdrawn to a second position, thereby
defining a treatment region between the distal end of the endoscope
50 and the proximal end of the viewing window 40 (FIG. 11B).
[0055] Referring now also to FIG. 11C, after the endoscope 50 is
withdrawn, light emitting fiber 60 may be extended through the
bores of apparatus 40, such that it projects into the treatment
region between the distal end of the endoscope 50 and the proximal
end of the viewing window 40. When the fiber 60 is extended, the
physician may irradiate the target region with light. The light,
which may take the form of laser emissions, passes through the
inner sheath 32 and the balloon 104 of the outer sheath/balloon 34
and is absorbed by portions biologic cavity in which it is
inserted, including the target region. The light delivered by the
fiber may be in the infrared, visible, and/or ultraviolet regions
of the spectrum, although if the intended treatment utilizes a
photosensitizer, the wavelengths of light will be specific to those
capable of activating said photosensitizer. The fiber that delivers
the light may be configured in a variety of geometries including
cylindrical, spherical and spot projection, with the preferred
embodiment being cylindrical.
[0056] After the target region has been effectively treated, the
combination of the endoscope 50, inner sheath 32, and outer sheath
34 may be removed in a manner similar to that by which the
combination was inserted. Specifically, the light emitting fiber 60
may be withdrawn back into the endoscope 50, and the endoscope 50
is pushed back to the first position at which its distal end is
proximate to the distal end of the inner sheath 32, while the
balloon 104 remains inflated. Subsequently, the balloon 104 may be
deflated. After deflating the balloon 104, the combination of the
endoscope 50, inner sheath 32, and outer sheath 34 may be removed
from the biologic cavity, such as an esophagus. Alternatively,
apparatus 10 may be left in place to facilitate effecting other
treatments or procedures, in which case endoscope 50 may be
withdrawn, and if necessary or desirable, balloon 104 inflated to
maintain its relative position in the cavity while endoscope 50 is
being withdrawn.
[0057] According to an aspect of the present invention, seal 80 may
take the form of a locking or passive seal.
[0058] According to an aspect of the present invention,
air/water/suction line 12 could be split into an air/water line and
a suction line. The air/water line would continue to use the hood
feature on the distal window for displacing the spray of fluid. The
suction line may be provided with a separate bore through the
distal window 40 that was not hooded, to allow direct suction for
example. An additional suction port could be positioned proximal to
the balloon to remove fluid build up during treatment. According to
an aspect of the present invention, air/water/suction line 12 could
be removed altogether, which could allow for the removal of the
outer sheath and the necessary bonding sites on the proximal
fitting 20 and distal window 40. In such a case, balloon 104 may be
adhered proximally and distally to the inner sheath 32. The inner
sheath 32 may be allowed to communicate with the balloon 104.
[0059] According to an aspect of the present invention,
air/water/suction line 12 could be removed altogether, which could
allow for the removal of the inner sheath and the necessary bonding
sites on the proximal fitting 20 and distal window 40. In such a
case, balloon 104 may be adhered proximally and distally to the
outer sheath. The outer sheath may be allowed to communicate with
the balloon 104.
[0060] According to an aspect of the present invention, the
inflation/deflation line could be removed and an air and suction
feature inherent to endoscope 50 used to inflate and deflate the
sheath respectively.
[0061] According to an aspect of the present invention, markings
may be provided so as to be viewable using endoscope 50. According
to an aspect of the present invention, reference points for
determining a distance that the endoscope is withdrawn for
treatment may take the form of markings at the distal end of the
air/water/suction line 12 within the region of the balloon 104,
inner sheath 32 or outer sheath 34, for example. This would allow
the user to directly view how far back endoscope 50 is moved.
[0062] According to an aspect of the present invention, it may be
desirable to at least partially inflate balloon 104 to improve
viewing through window 40.
[0063] Although the aforementioned describes preferred embodiments
of the invention, the invention is not so restricted. It will be
apparent to those skilled in the art that various modifications and
variations can be made to the disclosed preferred embodiments of
the present invention without departing from the scope or spirit of
the invention. For example, although the invention was described as
being used in a esophagus, it could be used in any biological
cavity sized to receive an endoscope (e.g., bladder, colon, etc.).
In addition, although the invention was described as treating
Barrett's Esophagus, it could be used to treat or diagnose other
diseases or ailments such as colon or bladder cancer.
[0064] According to an aspect of the present invention, fiber 60
may be replaced by, or supplemented with, another medical treatment
device or apparatus. By way of nonlimiting example, one or more
ultrasound applicators could be sheathed by apparatus 10 so as to
permit treatment, or the application of a procedure, to tissue via
a cavity in which apparatus 10 has been inserted.
[0065] Accordingly, it should be understood that the apparatus and
method described herein are illustrative only and are not limiting
upon the scope of the invention, which is indicated by the
following claims. Accordingly, alternatives which would be clear to
one of ordinary skill in the art upon reading the teachings herein
disclosed, are hereby within the scope of this invention.
* * * * *